Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498926

NN304-1685

2005-002481-11 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body mass index (BMI) between 18 and 27 kg/m^2, inclusive
• Non-smoker
• Fasting plasma glucose maximum 6 mmol/L

Exclusion criteria

• Known or suspected allergy to trial products or related products
• Previous participation in this trial
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
• The receipt of any investigational drug within the last 3 months prior to this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Glycerol

Experimental group

Treatment:

Drug: insulin detemir

Drug: insulin detemir

Mannitol

Active Comparator group

Treatment:

Drug: insulin detemir

Drug: insulin detemir